Manager, Medical Coding - Daiichi Sankyo

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Manager, Medical Coding is accountable for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize medical coding technology, processes, and standards. This position may manage multiple programs concurrently. This position will manage coding resources of assigned studies. This position requires a strong working knowledge of medical terminology concepts and industry standards and technical skills in coding data received from CROs and vendors. This position requires solid verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. This position requires a demonstrated ability to manage/lead people and a variety of projects concurrently. Additionally, this position possesses working knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management.

Responsibilities:

Leadership, Direction, and Strategy:

Responsible for medical coding deliverables for assigned programs meeting quality and time expectations for both in-house and outsourced studies. Provides medical coding expertise and guidance to the program teams regarding medical coding activities and deliverables. Directs activities of medical coders at the program level. Monitors quality of deliverables produced and escalates performance or quality issues. Participates in individual performance reviews if required. Contributes to the development and implementation of standardized operating procedures and standardized operating instructions across programs and organization. Proactively leads Coding dictionary up-versioning related activities (MedDRA and WHO Drug Coding dictionaries) including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development, Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to meet needs of the study and/or program. Participates in audits and inspections to provide study and/or program-level information as needed.

Project Management:

Responsible for on-time completion of medical coding activities under the outsourced and in-house operating models. Complies with the protocol, Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Works with external vendors, if applicable, to ensure quality and accuracy of coding agreements/specifications and resultant coded data. Proactively identifies potential risks to medical coding quality, integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution.

Functional Expertise:

Study Start-Up: Reviews protocol to identify need for specific medical coding conventions. Drafts medical coding conventions as applicable for the therapeutic area/indication. Reviews/approves study-related documents pertaining to medical coding requirements such as eCRF Specifications, listings, coding conventions, Data Management Plan, and dictionary coding synonym list. Coordinate with Data Operations Team on coding dictionary set up, registration of dictionaries, and responsible for user acceptance testing specification and execution.

Study Conduct:

Responsible for adherence of coding of medical terminology and medications to Daiichi Sankyo coding conventions. Reviews and submits DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and consistency of the coded data and adherence to regulatory requirements. Develops and maintains documentation of items on medical coding, including but not limited to Daiichi Sankyo coding conventions, coding decision logs, in-house and vendor-related coding reports, and up-versioning dictionary documentation. Produces coding reports for periodic predefined study team review. Compiles feedback provided and issues queries and actions site query responses. Performs medical coding line listing quality reviews for accuracy and consistency within and across programs on an ongoing basis to ensure data quality and adherence to established coding conventions. In collaboration with the Study Data Manager, monitors coding metrics and trends on a scheduled basis and proactively presents findings to the appropriate cross-functional team. Manages coding dictionaries (MedDRA, WHODrug) and/or supporting dictionary up-versioning and subsequently submits requests to update company specific synonym list. Responsible for the filing of Data Management coding documentation and approval/signatures forms in the TMF (Trial Master File) on an ongoing basis according to applicable Daiichi Sankyo and regulatory requirements.

Study Closure:

Accountable for medical coding completion and resolution of all coding-related queries prior to database lock. Conducts final coding listings review; distributes final coding listings for medical review and approval. Drafts the final coding approval form and coordinates approval. Responsible for the filing of final Data Management coding documentation and approval/signature forms in the TMF according to applicable Daiichi Sankyo and regulatory requirements.

Qualifications:Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's Degree required

• Coding Certification - Certified MedDRA Coder (CMC) or equivalent preferred

Experience:

• 4+ years of clinical data management medical coding experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) required

• Oncology, immunology, or complex disease clinical trial experience preferred

• Must have a strong understanding and utilization of medical terminology; experience in coding medical data (adverse events and concomitant medications) and understanding of the clinical coding process.

• Working knowledge of MedDRA, and WHO¬DD is required

• Working knowledge of Clinical trial data systems and/or EDC coding tools is a preferred

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.